10 October 2024 Machine learning-enabled drug discovery and development company insitro has announced the execution of three strategic agreements with Eli Lilly.
Danish dermatology specialist Leo Pharma has revealed plans to cut 200 jobs, marking the company’s fourth workforce reduction since 2022. 11 October 2024
Booster Therapeutics, a biotechnology company pioneering a new class of proteasome activator medicines to treat neurodegenerative and other diseases, has launched with the support of a $15 million financing. 11 October 2024
German cancer specialist Immatics has announced the pricing of its $150 million public offering, with Jefferies, BofA Securities, and Leerink acting as joint book runners. 11 October 2024
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech's latest COVID-19 vaccine, Comirnaty (KP.2). 11 October 2024
In what Astella Pharma calls “a landmark decision for advanced bladder cancer patients,” the Japanese drugmaker gained approval in the UK for its treatment regimen. 10 October 2024
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
China’s Quantum Pharmaceuticals has announced a significant licensing agreement between its biologics-focused subsidiary, Ailux Biologics, and Johnson & Johnson. 10 October 2024
USA-based Kezar Life Sciences announced this week that it was pausing its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 10 October 2024
Advances in gene editing, such as the FDA approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) in December 2023 for the treatment of beta thalassemia and sickle cell disease, have fueled significant interest in innovative epigenetic drugs. 10 October 2024
Gene therapy start-up GEMMA Biotherapeutics (GEMMABio) has announced a significant partnership with Brazil's Fiocruz, a key supplier for the Brazilian Ministry of Health. 10 October 2024
California’s Arda Therapeutics, a biotech focused on targeted cell depletion therapies for chronic diseases, has announced the successful completion of a $43 million Series A financing round. 9 October 2024
Purespring Therapeutics, a gene therapy company focused on transforming the treatment of kidney diseases, has raised £80 million ($105 million) in a Series B financing. 9 October 2024
Just a couple of months after it won European approval, Venclyxto (venetoclax) has been recommended for routine use alongside rituximab on the National Health Service (NHS) in England for previously-treated chronic lymphocytic leukemia (CLL). 18 January 2019
US biotech Amgen and Belgian drugmaker UCB, which are co-developing the investigational bone-forming monoclonal antibody Evenity (romosozumab), have welcomed a major step forward towards US approval of the drug. 17 January 2019
UK-based GlaxoSmithKline and the Medicines for Malaria Venture (MMV) have published positive Phase III data from two studies of Krintafel (tafenoquine) for the radical cure of malaria. 17 January 2019
Germany’s Boehringer Ingelheim said today it has initiated a capacity expansion at its commercial manufacturing site for biologics in China. 17 January 2019
French biotech firm Valneva, a leading pure play vaccine company, today announced the signing of a new contract with the US government Department of Defense for the supply of its Japanese encephalitis (JE) vaccine Ixiaro. 16 January 2019
China may offer a dynamic market for drug companies, but the country’s changeable policies and unique healthcare insurance system are among the major challenges faced by companies seeking launch excellence, reports The Pharma Letter’s local correspondent, Wang Fangqing. 16 January 2019
US Food and Drug Administration Commissioner Scott Gottlieb has issued a statement regarding the new policies the agency is implementing to advance the development of cell and gene therapies. 16 January 2019
China’s National Medical Products Administration (NMPA) has approved the marketing application for Linzess (linaclotide) for adults with irritable bowel syndrome with constipation (IBS-C) in China. 16 January 2019
Hitting one out of three primary endpoints has been billed as a success for Keytruda (pembrolizumab) as results were presented from KEYNOTE-181, a trial investigating the anti-PD-1 therapy for the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma. 15 January 2019
China's oncology drug market has grown rapidly in recent years. Revenue of the oncology drugs in China grew from 83.4 billion renminbi in 2013 to 139.4 billion renminbi ($20.65 billion) in 2017, representing a compound annual growth rate (CAGR) of 13.7%. 15 January 2019
The US Food and Drug Administration has approved Cabometyx (cabozantinib) tablets for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. 15 January 2019
The combination of the Bristol-Myers Squibb drugs, Opdivo (nivolumab) and Yervoy (ipilimumab), have received European approval for first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC). 15 January 2019
A global placebo-controlled, double-blind Phase II clinical study of varlitinib as a first-line therapy in HER1/HER2 co-expressing advanced or metastatic gastric cancer patients, comparing varlitinib plus mFOLFOX6 to placebo plus mFOLFOX6 did not meet the primary endpoint of significant reductions in tumor size after 12 weeks of treatment. 15 January 2019
A start-up that was founded by a group of investors led by Pablo Legorreta, the chief executive of biopharma investor Royalty Pharma, has announced the $62 million acquisition of inRegen and its affiliate, Twin City Bio. 14 January 2019
UK-based Seqirus, a subsidiary of the Australian biotech firm CSL Limited (ASX: CSL), has won European approval for a new cell-based seasonal influenza vaccine, Flucelvax Tetra (influenza vaccine). 14 January 2019
Chinese companies Ascletis Pharma and Suzhou Alphamab have signed a strategic collaboration and exclusive licensing agreement for the anti-PD-L1 drug KN035, to treat hepatitis B and other viral diseases in China. 14 January 2019
A University of Wisconsin-Madison researcher and his collaborators at the University of California, San Francisco have repurposed the gene-editing tool CRISPR to study which genes are targeted by particular antibiotics, providing clues on how to improve existing antibiotics or develop new ones. 14 January 2019